BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN PUMP

    MDR report key: 20797690 · Received November 26, 2024

    Report

    Report Number
    MW5162929
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    November 15, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    YOUNG PATIENT WITH TYPE ONE DIABETES WITH AN INSULIN PUMP FOUND UNCONSCIOUS WITH GCS (GLASCOW COMA SCALE) 7 AND NOW WITH SIGNIFICANT FINDINGS ON MRI BRAIN. SUSPECT PATIENT WENT HYPOGLYCEMIC FOR LONG PERIOD OF TIME DURING THE NIGHT. ADDITIONAL INFORMATION RECEIVED ON 03-DEC-2024 FOR MW5162929. CORRECTING PROCODE.

    Description of Event or Problem · 0

    YOUNG PATIENT WITH TYPE ONE DIABETES WITH AN INSULIN PUMP FOUND UNCONSCIOUS WITH GCS(GLASCOW COMA SCALE) 7 AND NOW WITH SIGNIFICANT FINDINGS ON MRI BRAIN. SUSPECT PATIENT WENT HYPOGLYCEMIC FOR LONG PERIOD OF TIME DURING THE NIGHT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 03-DEC-2024 FOR MW5162929. CORRECTING PROCODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613562 INSULIN PUMP AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Life Threatening| H| S